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uuuuuhhhhh...is it just me or is this WHO clinical trials database about 30 years overdue?!

Pharma firms told to end secrecy in drug trials

The World Health Organization (WHO) has rebuffed requests from the pharmaceutical industry to tone down its plans for openness in drug testing.

Industry groups had asked for critical details about clinical trials to be omitted from a new WHO database, which will bring together information on trials from around the world and provide each study with a stamp of approval. They argued that making such details public would amount to disclosing commercial secrets, and said that the information could be misused by patients desperate for a cure.

The WHO remained unconvinced by industry's pleas. "We said: give us your best case," says Ida Sim, a clinical-trials expert at the WHO who discussed the organization's plan with industry. "But it was clear that the strongest case was not sufficient to counter the need for transparency and other ethical arguments."

The system is being set up in part because major pharmaceutical firms have been accused of hiding evidence that some new drugs, such as anti-depressants, can be harmful. By bringing together data on all known trials, the WHO hopes to make it harder for drug companies to bury trials when the results do not go as planned.

Sim and her colleagues have discussed the matter with industry representatives and other stakeholders for more than a year, and the groups have moved closer on some issues. Drugs firms had, for example, initially asked for key trial data, such as the scientific name of the drug being tested, to be kept confidential at the start of the trial. Some firms now say they are happy to publish this information, along with the other data requested by the WHO.

But other issues continue to cause divisions. Most prominent is the WHO call for registrations of early-stage trials, which assess factors such as safety. Although drug firms routinely register advanced trials, they prefer to keep initial tests secret.

Beat Widler is a clinical-quality manager at Roche, headquartered in Basel, Switzerland. He says that the secrecy is necessary to stop rivals from building on proprietary research and also prevents patients from attempting to access treatments before the proper safety tests have been done.

"It's about eliciting false hopes," Widler explains. "About 80% of molecules that are tested never make it to market." He adds that Roche currently has no plans to comply with the WHO request on this point.

The WHO has no legal power to force firms to comply with its guidelines, but the standards it has announced could influence other players. The editors of several prominent medical journals were involved in the discussions and WHO officials hope they will publish only clinical trials that have been tagged with a reference number from the WHO database.

And An-Wen Chan, a colleague of Sim's, says the WHO is talking to the ethical review boards that are required to approve all trials, including early stages. Chan wants to persuade the boards to make registration a condition of ethical approval, although these discussions are only just beginning.

The WHO database, which will incorporate existing trial registries such as the US government's clinicaltrials.gov, is scheduled to launch within the next 12 months.

I agree Harry. It will be a struggle to make it happen, but it's worth a struggle I think. Here's another story...

Trials and transparency

May 19th 2006 - The Economist - WITHOUT clinical trials, there would be no new miracle drugs. Pharmaceutical researchers could not test the efficacy, safety or anything much else about potential new treatments. So it is a pity that drug trials are under a cloud thanks to several recent scandals.

In Britain a recent early-stage trial of TGN1412, a monoclonal antibody designed to treat leukaemia, went horribly wrong; half a dozen patients were left gravely ill with multiple organ failure. Elsewhere, critics accuse Merck of withholding data from trials of Vioxx, a painkiller, that suggest it causes a higher risk of heart problems. In New York, Eliot Spitzer, the attorney general, has accused GlaxoSmithKline of suppressing data indicating that Paxil, an anti-depressant, might increase the risk of suicide in some children. The ordinary punter can be forgiven for thinking that a process designed to get at the truth is being manipulated by drug firms.

Happily, the World Health Organisation (WHO) thinks it has a solution. In an article in this week's Lancet, the agency unveils the results of its two-year-long effort to forge a set of universal rules for disclosing data from clinical trials. At the moment, the industry can choose from various voluntary initiatives encouraging disclosure and dozens of registries, but it is governed by few hard-and-fast rules.

With its new manifesto, the WHO hopes to change all that. It outlines 20 data requirements that must be disclosed for all trials. Provocatively, it insists that all such information must be disclosed before the first patient is registered for a trial—even for early-stage trials.

This is unlikely to sit well with the pharmaceutical industry. Caroline Loew of PhRMA, the American drug industry's lobbying arm, argues that disclosing details such as an experimental compound's proper scientific name could tip-off rival researchers that a firm has found a novel dosing regimen or a new use for an old compound. That, argues Dr Loew, would deter innovation and lead to drug companies looking for new treatments using rivals' data rather than their own research. If so, the lobbyists mutter, it would be the death of the industry.

The fears are overblown. Full disclosure early in trials might indeed make it harder for firms to protect clever new ideas. But pharmaceutical companies should still enjoy patent protection. In any case, they already routinely look for clues as to what their rivals are doing. The WHO argues that transparency could even improve the efficiency of the drug discovery process. The same firm that loses its lead on one drug might catch up or beat rivals on three others using information gained from a newly transparent process.

Sidney Wolfe of Public Citizen, an American watchdog group, even argues that these new recommendations do not go far enough. Voluntary measures will always fail, he says, because “the ones that have the most to hide will be the ones that disclose the least.” This bias toward publishing only positive research, he argues, has led to the suppression of valuable data on drug failures and thus tainted decades of clinical trials. He thinks that only full disclosure required by law will be sufficient to restore public trust in the industry.

He may be right, but even Dr Wolfe concedes that such legislation is highly unlikely to pass through Congress. Given that, the WHO's new plan for standardising and strengthening the disclosure of clinical trial data seems a good start to restoring the public's faith in clinical trials. As Ida Sim, project co-ordinator for the WHO's International Clinical Trials Registry Platform, and her colleagues argue in the Lancet, “sunlight is the best antidote to such free-floating distrust.”

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